FDA Medical Device Recalls (openFDA)
Inter-Med Llc: Vista Dental Products CanalClean Endodontic Irrigation Kit, (1) 12mL - Chlor-XTRA, 6mL - SmearOFF + 92) + (2) 30ga Irrigation Tips + (1) Micro Aspirator with Tip, REF 504700
- Recall number
- Z-0011-2020
- Recalling firm
- Inter-Med Llc
- Product
- Vista Dental Products CanalClean Endodontic Irrigation Kit, (1) 12mL - Chlor-XTRA, 6mL - SmearOFF + 92) + (2) 30ga Irrigation Tips + (1) Micro Aspirator with Tip, REF 504700
- Status
- Terminated
- Initiated
- 2019-06-27
- Posted
- 2019-10-01
- Terminated
- 2021-08-10
- Reason
- The affected lots may be packaged in syringes which include an incorrect bung. The incorrect bung is made of a latex-free isoprene rubber material. After prolonged storage and exposure to contained solutions, the rubber bung may degrade due to chemical interaction with the bleach solution.
- Root cause
- Process control
- Action
- The firm initiated the recall by letter on 06/27/2019. The letter directed the consignee to quarantine the product and contact the returns department for return instructions.
- Quantity
- 377 units
- Distribution
- US, South Africa, Switzerland, Poland, Italy, Singapore, Australia
- Lot, serial or model codes
- No UDI Lot/Work Order Numbers: 2018-1192 2018-1473 2018-1742 2018-1999 2018-2386 2018-2741 2019-0047
- 510(k) numbers
- ["K082470"]
- PMA numbers
- not on file
- Product code
- KJJ
- Firm FEI
- 3000209941
- Firm city
- Racine
- Firm state
- WI
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28